Redefining the Role of Industry in Contemporary Healthcare

How can pharmaceutical companies adapt to a changing environment? Are they the source of the problem, or have they simply responded to US Food and Drug Administration mandates?

Published Online: January 29, 2014

John L. Fox, MD, MHA; Bo Gamble; and Cliff Goodman, PhD

So, just how can pharmaceutical companies adapt to a changing environment? Are they the source of the problem, or have they simply responded to US Food and Drug Administration mandates? Why should community oncologists care how drugs get created and approved? Sorting it out were John L. Fox, MD, MHA; Bo Gamble; and Cliff Goodman, PhD.

At the outset, Cliff Goodman, PhD, asked panelists to distill what lessons pharmaceutical companies could take from what they had heard. Bo Gamble, of the Community Oncology Alliance, began by saying that everyone at Patient-Centered Oncology Care 2013 gets the message: The time has come to pay for quality, and everyone must be on board.

What will drive change, Gamble said, is for that message to filter out to those who don’t get it. “A lot of the providers don’t and a lot of the payers don’t; certainly the patients don’t,” he said. Many

providers don’t grasp that reform is an “evolutionary,” process; it’s not something they can assign to a single time slot in each week.

Goodman then asked John L. Fox, MD, MHA, on behalf of payers, whether pharmaceutical companies—and the life sciences industry generally—are ready for change.

Fox said he often feels he has to be an ambassador of sorts for drug companies when he deals with providers or employers. It’s an uncomfortable spot, but it highlights a disconnect. He’s starting to see manufacturers develop patient navigation tools that do not steer consumers to a particular product, but it’s not commonplace. And the reason is obvious: right now, payers, providers, and patients bear the risk.

It’s time, he said, for “mutual accountability… for making sure the right patients are on the right therapy. Today the risk is ours alone, as a payer. Pharma really doesn’t have any skin in the game in ensuring that the right patients are on the right drugs.”

Does that mean, Goodman asked, that drugs should not be reimbursed if they don’t have certain health outcomes?

Essentially, Fox said, yes. “There should there be a minimum threshold for improvement. That would be ideal, as a starting point, to say we’re not going to bring anything to the market that’s a bunt single. We want to bring a double to market or a home run, but if it’s going to be a bunt single, I don’t want that.”

Gamble agreed, saying there should be a “comprehensive view” of drugs that make it to the market. With drug prices so high, it’s not easy for community oncology practices to transition to valuebased care.

“The thing about healthcare is, it’s been totally about utilization,” Gamble said. “You come in, you consume, you get a bill. There’s been no accountability, and we’re saying ‘No, think differently about everything you do.’ Think about quality, think about value. Prove it.”

Fox said there’s too much focus on which drug will be best for a condition, without asking about factors that affect whether it works—such as side effects and whether the patient can afford it.

“But,” Goodman interjected, “the life sciences companies have been oriented over the decades—many decades—toward getting some kind of regulatory approval based on certain biomarkers or some sort of end points. Have they been in the business of adherence and medication management and whether or not your drug reduces readmissions?”

“No, but they need to be,” Gamble said. “We’re also asking the practices to gear up for that, we’re asking the patients to gear up for that. … It needs to look like the Angie’s List of healthcare; what is the quality and the value component here?”

Goodman asked Fox whether healthcare reform would change the life sciences industry. “If they’re just cranking out molecules—some that you can swallow, some that have to be injected—is that still a viable long-term approach given the healthcare demand and the things for which you intend to pay?”

Fox said what payers want to see are drugs that help people live longer, with good quality of life. Today’s attitude, he said, is “My only job is to produce a drug; if it’s everybody else’s job to make sure the patients take it and to get the best possible outcomes, then that’s not a partnership, that’s not mutual accountability. Yet, how do we define what mutual accountability looks like?” Other diseases, typically chronic diseases, have support programs that go beyond making sure patients take their medicine.

Goodman asked if anyone in the pharmaceutical industry wanted to respond.

One respondent said what’s needed is a uniformed, structured approach. To one individual, incremental benefit may be a huge benefit, depending on the person’s circumstances. What is success? When do you abort a trial?

Fox said what this points to is “patientrelevant outcomes.” The oncology community— including drug makers—must ask patients what is more important: living longer, or living longer without chemotherapy? Is the answer different from what it is for an oncologist?

Tom Morrow, MD, of Genentech, said the work of drug companies has brought cancer care forward; many cases that had no hope now can become chronic conditions.

Overall survival is a hard standard, because it’s not measurable. “Can we do overall survival when we have control of the patient over a period of time that they’re willing to put themselves under our control?” Progression-free survival is the FDA goal.

Goodman said Genentech was “one of the most innovative companies.” Did more need to be done with payers? Morrow said Genentech has a fleet of staff

who work with payers, but drug makers need “really close definitions of what they want.” Drug development still takes 10 years—which is a huge investment of time and money.

Fox ended this way: “One of my favorite quotes is from Indira Gandhi, and she said it’s hard to shake hands with a clenched fist, and I don’t think that we’ll solve this problem without collaboration. I think it’s one, however, that has to be around shared accountability.” EBO